Japan has no pre-market approval for ordinary supplements and no product registration certificate to obtain. In that sense it is the most open market in this series after the United States.
The difficulty sits somewhere else entirely. Japan decides whether your product is a food or a drug based on its ingredients, its dosage form and how it is presented — and that determination is made before anything else matters. Get it wrong and your shipment is not a slow approval; it is an unlawful import of an unapproved pharmaceutical.
This page is general regulatory information, not legal advice.
Japan regulates pharmaceuticals under the Pharmaceuticals and Medical Devices Act (PMD Act) and food under the Food Sanitation Act. A supplement sits in the food column only if it stays clear of the pharmaceutical column, and three things can push it across:
those treated as pharmaceutical. A botanical or extract routine in Korea may be classified as a drug ingredient in Japan. This is the most common failure for Korean products, because Korean individually approved functional ingredients (개별인정형) often have no Japanese food-use precedent.
pharmaceutical-style formats — suggest a drug regardless of contents.
a drug in Japan's view even if the composition is unremarkable.
Ask your prospective importer to confirm classification before you quote anything. Quarantine stations operate advisory desks for exactly this, and Japanese guidance explicitly recommends prior consultation for supplements, health foods and products using novel materials. A one-hour question saves a rejected container.
Assuming the product is a food, each shipment requires a food import notification (食品等輸入届出書) to the Ministry of Health, Labour and Welfare, filed at the quarantine station under Article 27 of the Food Sanitation Act.
reaches the port or airport
is required; food sanitation inspectors assess conformity with the Act and its manufacturing standards
There is no product registration. No certificate is issued that you hold and reuse. Each shipment is notified. The corollary is that regulatory readiness must be complete before import, not after arrival — there is no mechanism for fixing a problem while the goods sit in a warehouse.
colourant or preservative routine in Korea may not be permitted
Repeat shipments of an identical product from the same manufacturer are simpler, since the importer can reference the earlier notification.
Japan runs a structured framework administered by the Consumer Affairs Agency. Which tier you choose determines cost, timeline and what you may say.
The default. No notification of claims, no approval. You may describe the product and its ingredients but may not state a health function.
Most first Korean entries sit here. It is the fastest route and carries no claim risk.
A self-certification tier for specified vitamins and minerals meeting prescribed intake ranges, using fixed statutory wording. No notification required.
For a Korean vitamin or mineral product this is often the practical sweet spot — it permits a nutrient function statement with no filing, provided the content falls in range and the wording matches exactly. Check your dosages against the Japanese ranges; Korean formulations are frequently higher.
Introduced in 2015 and now the main route for functional claims. It operates on notification, not approval:
CAA 60 days before market launch
published literature
The operator bears the liability, which matters commercially: whoever files carries responsibility for the claim's validity. If your Japanese partner files, they carry it — and they will price that risk into the relationship. Agree who files and who indemnifies before launch.
The 1991 tier requiring formal government approval based on human clinical trials for the specific claim. Measured in years, and few products carry the mark. Not a realistic starting point for a new import, but worth knowing the mark exists so you understand what a competitor carrying it has invested.
Foreign-language packaging alone is not sufficient for retail sale. A Japanese label under the Food Labelling Act is required, and the mandatory nutrition declaration lists energy, protein, fat, carbohydrates and sodium expressed as salt equivalent, in that order — a prescribed sequence, not a translated Korean nutrition panel.
Also required: name, ingredients, additives, net content, best-before date, storage conditions, importer name and address, allergen declarations, and country of origin.
Allergen rules differ from Korea's. Check your formulation against the Japanese mandatory and recommended allergen lists rather than assuming the Korean declaration transfers.
Korean MFDS-approved claim wording carries no weight. Anything implying disease treatment or prevention takes the product into PMD Act territory.
| Stage | Typical duration |
|---|---|
| Classification consultation with quarantine station | 1–3 weeks |
| Assembling Korean documentation | 2–4 weeks |
| Japanese label development | 2–4 weeks |
| Import notification and clearance, first shipment | Days to weeks, depending on inspection |
| FFC notification, if pursuing functional claims | 60 days before launch, plus evidence preparation |
| To first sale, ordinary food route | 6–10 weeks |
| With FFC | add 3–6 months |
Comparable to the United States for speed on the plain route, and considerably faster than Vietnam, Indonesia or China.
Korea and Japan have no bilateral free trade agreement, but both are parties to RCEP (the Regional Comprehensive Economic Partnership), which entered into force in 2022. Preferential rates may be available under RCEP for your HS code.
Ask your Korean supplier about RCEP origin documentation. It is newer than the ASEAN or US arrangements and is sometimes overlooked by exporters used to older agreements.
and individually approved Korean ingredients
healthcito.com compiles publicly available regulatory information. Reviewed 11 August 2026. This page is general information, not legal advice — confirm current requirements with MHLW, the Consumer Affairs Agency, your local quarantine station or a qualified consultant before acting. Supported by GNMLIFE, Inc.
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